Priority Review Fee definition

Priority Review Fee has the meaning set forth in Section 12.3.
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Priority Review Fee means the fees described in 21 U.S.C. 360bbb-4a(c).
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Priority Review Fee has the meaning given is Section 529(c) of the FFDCA. (jj) “Priority Review Voucher” means the priority review voucher issued by the Secretary of the Department of Health and Human Services pursuant to Section 529(b)(1) of the FFDCA to Seller and assigned tracking number PRV NDA 218709 that entitles the holder of such voucher to Priority Review of a single human drug application submitted under Section 505(b)(1) of the FFDCA or section 351(a) of the PHSA. (kk) “Purchased Assets” means (i) the Priority Review Voucher and (ii) any and all rights, benefits and entitlements with respect thereto afforded to the holder of such Priority Review Voucher. (ll) “Rare Pediatric Disease” means rare pediatric disease as defined in Section 529(a)(3) of the FFDCA. (mm) “Representative” means, with respect to a particular Person, any director, officer, manager, employee, agent, consultant, advisor, accountant, financial advisor, legal counsel, or other representative of that Person. (nn) “SEC” has the meeting set forth in Section 5.3. (oo) “Tax” or “Taxes” means [***]. (pp) “Third Party” means any Person other than a Party and such Party’s Affiliates.
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Examples of Priority Review Fee in a sentence

  • The Priority Review Fee and all other user fees under the FDCA applicable to the human drug application for which the Priority Review Voucher is redeemed, following the Closing, shall be borne exclusively by Buyer, its Affiliates or any transferee of the Priority Review Voucher.

  • In furtherance and not in limitation of the foregoing, Buyer shall timely pay all amounts due with respect to the Priority Review Fee in connection any submission of a Pre-Closing PRV Notice as contemplated by Section 4.1 or other Notice of Intent to Use the Priority Review Voucher by Buyer.

  • Neither Seller nor any of its Affiliates has filed or submitted to the FDA, or instructed or permitted any Third Party to file or submit to the FDA, a Notice of Intent to Use the Priority Review Voucher to obtain a Priority Review or paid a Priority Review Fee in connection with the Priority Review Voucher.

  • The Priority Review Fee and all other user fees under the FDC Act applicable to the human drug application for which the Priority Review Voucher is redeemed shall be borne exclusively by Buyer or any transferee of the Priority Review Voucher.

Related to Priority Review Fee

  • Review Fee has the meaning stated in Section 4.3(b).

  • Initiation fee means a fee charged by us to you in order to create a credit facility for you;

  • Liquidation Fee The fee designated as such in, and payable to the Special Servicer in connection with certain events in respect of a Specially Serviced Mortgage Loan or an Administered REO Property pursuant to, Section 3.11(c).

  • Distribution Fee means a percentage of MRP of each of the Subscribed Channels payable by SDSPL to the Licensee towards fee for distribution of each of the Subscribed Channels as more specifically specified in Annexure B and Annexure B-1 of this Agreement.

  • Sewage sludge fee weight means the weight of sewage sludge, in dry U.S. tons, excluding admixtures such as liming materials or bulking agents. Annual sewage sludge fees, as per section 3745.11(Y) of the Ohio Revised Code, are based on the reported sludge fee weight for the most recent calendar year.

  • Professional Fee Amount means the aggregate amount of Professional Fee Claims and other unpaid fees and expenses that Professionals estimate they have incurred or will incur in rendering services to the Debtors prior to and as of the Confirmation Date, which estimates Professionals shall deliver to the Debtors as set forth in Article II.B of the Plan.

  • Additional Fee means a fee, in addition to the licence fee, imposed by the municipality on a business at any time during the term of the licence for costs incurred by the municipality attributable to the activities of the business;

  • Agent’s Fee means the fee which is set out in this Agreement and which is payable by the Issuer to the Agent in consideration of the services performed by the Agent under this Agreement;

  • Noteholder Servicing Fee is defined in Section 3.1.